Our Team provides a wide range of services at an expert level. Gained through years of education, work experience, and management experience, we are happy to use our accumulated skills to fit your company’s needs.
1. Medical review of individual case reports (e.g., AE, SAE, ESR, SUSAR); AE Case Entry (ICH E2B Standard), MedDRA Coding, WHO Drug Coding, narratives writing, query tracking, targeted follow-up. Individual Case Safety Reports require analysis of information to track consistency of case narratives and source documents. They require medical evaluation completed by medical professionals and include evaluation.
2. Early Phase Medical Safety Monitoring entails obtaining an initial understanding of the safety profile, designing the optimal solutions for Phase II studies, evaluating expected safety issues, and vigilant monitoring of known safety issues. Developing an Early Phase Safety Profiles is a multistep process and requires parsing of incoming data into manageable and identifiable signals for assessment. This raw information-to-interpretation informs if and how the Phase I and Phase II continues.
3. As part of safety monitoring, Safety Signal Detection and data mining (e.g., MGPS), requires a keen sense and deep understanding of medical information so that signals can be detected and noise ignored. Failing to detect signals can lead to dangerous errors and costly liability; while anyone can type or set automatic search terms, our experts are trained and have years of experience that go beyond the search terms. We are responsible for searching: Labs, ECG, Holter Data Summary, development of targeted questionnaires for AEoSIs, integrated review of clinical trials data across protocols or programs, and Pharmacoepidemiology review.
4. Risk Management planning and development describes the stage of development that interprets detected signals and develops a plan to evaluate, minimize, and communicate the possible risks involved.
Our experts develop: risk data summaries, risk minimization activities, ongoing evidence-based risk/benefit assessments, RMP related PV activities (PSUR, PBRER, CCDS/product labeling update, safety studies), and overall assessment of benefit/risk balance.
6. Our team’s expertise in Safety Data Integration Analyses for IND and NDA applications, stems from having a strong track record of successful IND and NDA applications. Our hands-on experience in communicating with governmental agencies on safety related matters, has given us the ability to guide clients through stringent regulatory practices. Through years of work, our experts have established professional networks and relationships within the medical safety world to help clients as they develop their products.
7. Another expert field the G2 provides is identification of Drug Induced Live Injury. Dealing with live injury and rare subjects may sometimes feel like finding a needle in a haystack, but our expert team has real-world experience narrowing down subjects within large controlled clinical studies.
8. PV medical safety assessment trainings are also available and taught by a member of our expert medical team. Topics include (but are not limited to): PV SOPs/ WIs/ templates development. We can also help Develop Company Safety Documents and Local Labels as needed.